BERLIN – The Medical Device Regulation (MDR) that reforms the European Union's (EU) rules for earning a CE mark have knocked out another leg of the stool that supports U.S. manufacturers.
Already the number of Notified Bodies (NB) that grant the CE mark has been reduced from more than 80 to less than 60, and by 2019 that number is projected to drop to just 46 designated companies. (See BioWorld MedTech, April 19, 2017.) Read More
